Phathom Pharmaceuticals Inc. shares tumbled 27% to $8.70 in after-hours trading Tuesday following a decision by the Food and Drug Administration to take no action on the company's new drug application for vonoprazan.
The biopharmaceutical company said it no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023. The outlook comes after it detected trace levels of nitrosamine impurity in commercial batches in August. The company said at the time it was working with the FDA to obtain approval of a proposed acceptable daily intake limit, test method and controls to address the impurity before releasing vonoprazan, a potassium-competitive acid blocker, based products to the market.
Phathom said the FDA has requested additional stability data demonstrating that levels of nitrosamine remain below the limit throughout the proposed shelf life of the product despite an acceptable daily intake limit for the nitrosamine impurity being established.
"While we are disappointed not to launch vonoprazan later this quarter, we are otherwise very pleased with the NDA review progress, including ongoing label negotiations which we are optimistic will conclude shortly, " said Chief Executive Terrie Curran.
Trading was halted at 4 p.m. EST ahead of the news and resumed 30 minutes later. The stock, which closed up 6.9% to $11.99 in regular trading, is down 40% over the last 12 months.
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